- Proprietary Oral NCE Designed to Improve Gastrointestinal Motility in Patients Taking Opioid Analgesics -
- Preclinical Comparisons with Active Agents in this Class Indicate ALKS 37 has Potential to be Efficacious at Lower Doses and for an Extended Period of Time with Low Systemic Exposure -
According to
"While opioids are a common and effective treatment for managing chronic
pain, the side effects of these medications can be debilitating and may
diminish patient adherence to pain medication," stated
“Our unique understanding of opioid biology and pharmacology allowed us
to take a very innovative approach to the development of a GI-targeted
therapy such as ALKS 37,” said Dr.
ALKS 37 Study Design
The phase 1 study of ALKS 37 is a randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability and pharmacokinetic effects of a single oral administration of five doses of ALKS 37 in approximately 40 healthy volunteers. Initiation of this trial is based on preclinical studies that showed ALKS 37 demonstrated the potential to reverse opioid agonist effects on gastrointestinal motility with low systemic exposure and little or no CNS penetration. Preclinical data also showed that oral administration of ALKS 37 had greater efficacy at a lower dose and for an extended period of time compared to an active comparator, methylnaltrexone. The company expects to report top-line results from the study in the first half of calendar 2010.
In addition to ALKS 37,
About Opioid Modulators
Opioid modulators can act as antagonists, agonists or partial agonists at opioid receptors throughout the body. Emerging biological research and new medicinal chemistry insights now allow for the development of novel opioid modulators with the potential to show enhanced activity at opioid receptors and could ultimately lead to improved therapeutics.
About
Certain statements set forth above may constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, including, but not limited to the potential
therapeutic value of Alkermes’ proprietary molecules targeting opioid
receptors, including ALKS 37 and ALKS 36, and Alkermes’ plans to
continue development of such proprietary molecules. Although the company
believes that such statements are based on reasonable assumptions within
the bounds of its knowledge of its business and operations, the
forward-looking statements are neither promises nor guarantees and the
company’s business is subject to significant risk and uncertainties and
there can be no assurance that its actual results will not differ
materially from its expectations. These risks and uncertainties include,
among others: whether preclinical results will be predictive of clinical
results; whether the phase 1 clinical trial discussed in this release
will be completed on time or at all; potential changes in cost, scope
and duration of the clinical trial; and whether ALKS 37 and ALKS 36 will
be approved by regulatory authorities and subsequently commercialized.
For further information with respect to factors that could cause the
company’s actual results to differ materially from expectations,
reference is made to the reports the company filed with the
VIVITROL® is a registered trademark of
Source:
Alkermes Contacts:
For
Investors:
Rebecca Peterson, 617- 583-6378
or
For Media:
Jennifer
Snyder, 617-583-6166